Astellas Pharma news from FierceBiotech
NewsAstellas faces new delay for Advagraf approval
Japan's Astellas Pharma has run into a new roadblock in its pursuit of regulatory approval of Advagraf, its second generation version of the blockbuster transplant drug Prograf. The FDA has raised Read more...
Astellas pays $760M for Alzheimer's program
Another day, another big biotech deal. This time it's Japan's Astellas Pharma, which is paying $760 million for access to CoMentis's Alzheimer's drug. The development and commercialization agreement Read more...
CV scores $185M royalty deal on Lexiscan
Just a week after gaining regulatory approval for Lexiscan (regadenoson), an injection that increases Read more...
CV, Astellas gain Leixscan approval
CV Therapeutics and Astellas Pharma have won FDA approval of Lexiscan, a A2A adenosine receptor agonist intended for use during heart stress tests. Almost half the patients undergoing cardiac stress Read more...
ALSO NOTED: Novartis sinks$816.5M into Italian vaccine plant; GSK, Astellas take a pass on Theravance's drugs; and much more...
> Novartis is pledging to sink €600 million ($816.5 million) into new and expanded facilities in Italy. Read more...
SPOTLIGHT: Cardiome, Astellas get panel date
The FDA as extended its review of a new therapy for abnormal heart rhythm and asked Cardiome and Astellas to sit in on a panel review of the drug. The panel review will be held on December 11 and 12 Read more...
Press Release: Astellas Receives an Action Letter from FDA for NDA of FK506 MR in the U.S.Press Release: Astellas Receives an Action Letter from FDA for NDA of FK506 MR in the U.S. Read more...Astellas faces FDA delay on reformulated PrografThe FDA has issued a nonapprovable letter to Japan's Astellas Pharma for a new formulation of its drug Prograf for heart transplant patients. But the agency also said that the drug was approvable for liver and kidney patients while asking for additional information before a final decision is made. That delay sent shares of Astellas down more than five percent, although company officials said they had not given up hope of an approval. The patent on Prograf, which earned $1.4 billion last … Read more...CV, Astellas present positive Phase III resultsCV Therapeutics and Astellas Pharma have announced that the second of two Phase 3 clinical studies of regadenoson met its primary endpoint. A prior identically designed Phase 3 study, completed in 2005, also met its primary endpoint. Regadenoson is used in myocardial perfusion imaging studies. "With two identically designed Phase 3 studies having hit their primary endpoints, we are excited about the opportunity to pursue approval of regadenoson. We are also pleased that regadenoson once … Read more...Press Release: Regadenoson Meets Primary Endpoint in Second Phase 3 Clinical TrialPress Release: Regadenoson Meets Primary Endpoint in Second Phase 3 Clinical Trial Read more... | Press ReleasesCV Therapeutics and Astellas Pharma Announce FDA Approval for Lexiscan Injection CV Therapeutics and Astellas Pharma Inc. Announce FDA Approval for Lexiscan Injection 4/11/2008 PALO ALTO, Calif. and DEERFIELD, Ill., April 10 -- CV Therapeutics and Astellas Pharma US, Inc. today Read more... PRESS RELEASE: Astellas to Acquire Agensys Astellas to Acquire Agensys Japan, November 27, 2007 - Astellas Pharma Inc. (“Astellas”; headquarters: Tokyo; President and CEO: Masafumi Nogimori) today announced that its US subsidiary, Read more... PRESS RELEASE: Theravance Says Retains Rights to Develop Two Drugs Theravance Says Retains Rights to Develop Two Drugs SOUTH SAN FRANCISCO, CA -- Sep 6, 2007 -- Theravance today announced that GlaxoSmithKline has elected not to exercise its option to license Read more... PRESS RELEASE: Cardiome Pharma and Astellas Pharma U.S. Announce PDUFA Action Date Extended by Three Months Cardiome Pharma and Astellas Pharma U.S. Announce PDUFA Action Date Extended by Three Months VANCOUVER, and DEERFIELD, IL, Aug. 30 - Cardiome Pharma Corp. and its co-development partner Astellas Read more... |
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